Consumer attitudes and the political climate leading up to the passage of the Dietary Supplement Health and Education Act (DSHEA)

In 1993 and 1994, there was a growing, national dialog about improving healthcare, so from both political and consumer perspectives, healthcare was a topic of increasing importance. President Bill Clinton had recently taken office, and he put First Lady Hillary Clinton in charge of his healthcare task force to address reform. This ultimately led to the proposed Health Security Act (HSA).

Sen. Orrin Hatch, R-Utah, was a key voice on health issues as one of the few Senate members who sat on both the Labor Committee and the Finance Committee; these two committees have jurisdiction over all healthcare programs. Hatch was a leading critic of the HSA, and as a former chair of the Labor Committee, he was recognized by his colleagues for his public health acumen. By August of 1994, the Utah senator and his Republican colleagues had driven a stake in the heart of the Clintons’ effort.

At the same time, however, in the minds of consumers, dietary supplements were strongly linked to the concepts of improving healthcare and taking personal control of one’s own health to stay healthy longer and potentially avoid the onset of chronic disease and the side effects of pharmaceuticals. Statistics at the time indicated that at least 100 million Americans regularly used vitamins and minerals to improve diet and health. There was also increasing scientific studies appearing about the benefits of dietary supplements.

In addition, there was a growing awareness by many consumers, those in the industry and then Congress, that the Food and Drug Administration (FDA), the government agency that has regulatory jurisdiction over the vast majority of consumer products, including dietary supplements, had been heavy-handed with its regulatory approach to supplements for more than three decades.

The efforts of consumer groups and industry to bring these concerns to the attention of Congress paid off. Legend has it Congress received more correspondence about maintaining access to dietary supplements than at any other time except for letters regarding the Vietnam War.

Timeline of events leading up to the passage of DSHEA

1962: FDA set minimum/maximum levels for dietary supplements, but the proposal was withdrawn.

1976-1979:

April 22, 1976: Congress passed the Proxmire Amendment, the vitamin and mineral amendment to the Food Drug and Cosmetic Act. The legislation prohibited FDA from establishing standards to limit potency of vitamins and minerals in food supplements or regulating them as drugs based solely on potency.

FDA later proposed regulations on labeling/content of dietary supplements. For example, FDA tried to classify doses of more than 150 percent of a nutrient’s Recommended Daily Allowance as an over-the-counter drug. This proposal was withdrawn statutorily by the Proxmire Amendment.

1980: FDA again tried to place potency limits on vitamins and minerals, but the proposal was withdrawn.

1990: Congress enacted the Nutrition Labeling and Education Act, giving FDA the authority to approve disease prevention claims for foods, including dietary supplements. The passage of the act prompted FDA Commissioner David Kessler, M.D., to try to regain what he felt was regulatory ground lost to the supplement industry. His ongoing policy was a key factor in mobilizing the grassroots efforts to maintain supplement access and led to passage of DSHEA.

1991: FDA proposed regulation stating that herbs are not eligible for health claims because they are not nutrients.

1992: Sen. Orrin Hatch, R-Utah, introduced a one-page bill that would permit claims for supplements with no safety requirements. This legislation became the Health Freedom Act of 1992, which later served as a placeholder to keep FDA at bay until DSHEA passed. Hatch also authored a provision, enacted as Title II of the first Prescription Drug User Fee Act, to delay bringing dietary supplements into the NLEA regulatory scheme Congress had set for foods.

FDA continued its heavy-handed efforts with folic acid. Despite a long history of Centers for Disease Control recommendations and Public Health System endorsement of folic acid use by pregnant women and those of childbearing age to reduce neural tube defects, FDA continually refused to allow dietary supplement manufacturers to use this information on products.

April 7: DSHEA is introduced in the Senate and the House, co-sponsored by Hatch and Rep. Bill Richardson, D-N.M.

June: FDA’s Dietary Supplement Task Force issued “The Dykstra Report,” making recommendations on “improvements” to FDA’s regulatory program for dietary supplements. The recommendations caused a huge public outcry when the report was issued. The recommendations in the report, which contradicted DSHEA, were invalidated once DSHEA was signed into law.

July 29: A hastily drawn and inaccurate FDA report, “Unsubstantiated Claims and Documented Health Hazards in the Marketplace” was released at a House subcommittee hearing chaired by Rep. Henry Waxman, D-Calif.

October 21: Hatch releases a report rebutting Kessler’s “Unsubstantiated Claims” report at a hearing called by Sen. Edward Kennedy, D-Mass., on dietary supplement regulation. The Hatch report, “False and Misleading,” documented point by point the glaring errors in the FDA report. As Hatch noted, the report was literally riddled with inaccuracies; for example, it called CoQ10 a book and cited stores for selling supplements they didn’t even carry.

1994:

May 11: DSHEA, a bipartisan measure authored by Sens. Hatch and Tom Harkin, D-Iowa, is reported favorably during a Senate committee markup of DSHEA. The committee strongly rejects a substitute bill from Committee Chair Kennedy, reportedly the first time he had lost a vote in his own committee.

August 13: A revised DSHEA was approved by unanimous consent in the Senate. Even though the Senate was under Democratic control, Hatch was allowed to bring the measure up and offer it for passage.

October 7: Two-year, bicameral congressional negotiations had failed to yield a compromise acceptable to Hatch and Harkin. UNPA is summoned to Washington by Hatch, as he briefs industry on the status of the negotiations and plots future strategy. That afternoon, Waxman yields and offered a draft compromise, which was largely acceptable. The key senators and representatives quickly assembled in the Capitol Building to finalize an agreement, and congressional staff then raced to legislative counsel to draft the bill. In the waning hours of the 103rd Congress’ legislative session, at 2:49 a.m., Chair Waxman brings the agreement up for consideration, and it is approved by unanimous consent in the House. The next day, the very last day of the session, Hatch brings the bill up, and again, it is approved by unanimous consent in the Senate, thus clearing it for consideration by the president.

October 25: President Bill Clinton signed DSHEA into law, saying at the time: “After several years of intense efforts, manufacturers, experts in nutrition, and legislators, acting in a conscientious alliance with consumers at the grassroots level, have moved successfully to bring common sense to the treatment of dietary supplements under regulation and law.”

Why did DSHEA pass when so many other bills didn’t?

The Dietary Supplement Health and Education Act of 1994 (DSHEA) passed because the climate was right. It passed twice in the Senate by unanimous consent and once in the House by unanimous consent.

The Clinton administration’s emphasis on healthcare reform helped to bring the issue of access to supplements into the limelight, which was quickly recognized as a non-partisan issue for consumers. It was seen as a matter of fairness and of allowing the American public access to safe dietary supplements and information about their benefits. These strongly held public beliefs prompted unprecedented grassroots support leading up to DSHEA. The mail from consumers concerned about losing access to supplements was crushing, according to congressional staff members who worked on Capitol Hill at the time. Nearly all consumers that shopped at a health food store were asked to sign a petition to Congress in support of DSHEA.

Perhaps as a result of this widespread consumer concern, the passage of DSHEA could be considered a study in bipartisan politics. Sen. Orrin Hatch, R-Utah, working with Sen. Tom Harkin, D-Iowa, and lead House sponsor Bill Richardson, D-N.M., were successful in showing other members of Congress that FDA was out of control in its bias against dietary supplements. Sponsor by sponsor, Hatch grew the roster of cosponsors for the bill, working closely with Richardson, until ultimately, a majority of the House and Senate committees of jurisdiction, and the House and Senate themselves, agreed that FDA lacked a clear regulatory system for supplements and, as such, cosponsored DSHEA.

The initiative was clearly bipartisan from the beginning because the central authors realized that with a Democratic Senate, House and president, the only chance of enactment was through a bill that was solidly represented on both sides of the aisle.

In the end, the key to speedy passage of the final bill may be that it was negotiated directly by the principals, working off the Hatch draft. Reps. Henry Waxman, D-Calif., John Dingell, D-Mich., along with Richardson, Hatch and Harkin were all there at the table in Richardson’s Capitol Hill office on the very last day of Congress in 1994. As Hatch had predicted, it came down to the wire. Chairman Waxman in the House brought up the final bill, and Hatch brought up the bill in the Senate.

Passage of DSHEA was both a legislative victory for Hatch, Harkin and Richardson, but more importantly, it was a tremendous win for consumers. The solid support for it was indicated by the fact that the bill passed by unanimous consent in both the House and Senate. And the solidness of the compromise negotiated is indicated by history, with relatively few problems over the last two-plus decades and no major amendment or legislative challenge to its structure in more than 20 years.

After several years of intense efforts, manufacturers, experts in nutrition, and legislators, acting in a conscientious alliance with consumers at the grassroots level, have moved successfully to bring common sense to the treatment of dietary supplements under regulation and law.